Packageless Syringe Assembly With Sterilizable Fluid Path

ABSTRACT

Syringe assemblies comprising a first cap and a second cap to ensure sterilization of the fluid path without the need for external packaging are described. Also described are methods of sterilizing the fluid path of a syringe assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/549,652, filed on Jul. 16, 2012, the disclosure of which isincorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to syringe assemblies, and moreparticularly to syringe assemblies in which the fluid path can bemaintained in sterile condition without the presence of externalpackaging surrounding the syringe assembly.

BACKGROUND

Clean or sterile articles particularly useful for medical applicationsare packaged to preserve their sterility. The packaging for thesearticles is intended to provide a barrier to prevent microorganisms fromentering inside the packaging to contaminate its contents. In mostinstances, the packaging is opened immediately prior to using thesterile article, such as with a blister pack housing a syringe assembly,so as to minimize the time period in which the sterile article isexposed to unsterile conditions.

When the packaging used to protect sterile articles such as syringeassemblies is opened and the syringe assembly is removed, the packagingthen needs to be discarded, leading to an increase in the amount ofwaste material produced in a hospital or other medical setting.Additionally, when packaging is used to contain each individual syringeassembly or a number of syringe assemblies, the cost of providing thepackaging contributes significantly to the cost of each syringe assemblyproduct. It is desired that a syringe assembly be manufactured at as lowa cost as possible, thus reducing the price at which the syringeassembly can be sold.

In addition to the costs associated with external packaging, packagingused to protect sterile articles tends to be bulky and, consequently,consumes more storage space per unit than is desirable. Thus, the use ofpackaging to contain the syringe assembly adds additional andunnecessary bulk to each individual syringe assembly. This additionalbulk significantly detracts from valuable storage space in a hospital orother medical storage area.

It would be advantageous to provide a syringe assembly consisting of theusual components that does not provide packaging surrounding the syringeassembly, but is able to maintain a sterile fluid path prior to use.

SUMMARY

Embodiments of the present invention are directed to a packagelesssyringe assembly. Syringe assemblies according to a first aspect of thepresent invention include a plunger rod, a syringe barrel, and a firstand second cap that permit sterilization of a portion of the fluid pathby radiation or a gas. The features providing for sterilization of thefluid path allow the fluid path to remain sterile without the need forexternal packaging material surrounding the syringe assembly.

In one or more embodiments, the barrel includes a side wall having anoutside surface and an inside surface defining a chamber for retainingfluid, an open proximal end, and a distal end including a distal wall,the chamber, distal end and proximal end defining a fluid path.

In one or more embodiments, the plunger rod includes a stopped disposedwithin the barrel.

In one or more embodiments, the first cap has a proximal end having afirst segment that is radiation and gas permeable and is in flowcommunication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas, and an open distal endaffixed to the proximal end of the barrel, wherein the first capproximal end is optionally covered by a first permeable material. In oneor more embodiments, the first permeable material comprises Tyverk® or amedical grade material with a porosity of 8-400 seconds/100 mL. In oneor more embodiments, the proximal end of the first cap includes acircumferential lip defining a recess containing a first permeablematerial. In a specific embodiment, the first cap includes an interiorsurface having a plurality of tortuous path rings.

In one or more embodiments, the second cap is affixed to the distal endof the barrel, and the second cap has a proximal end and a closed distalend having a segment that is radiation and gas permeable and is in flowcommunication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas. In one or moreembodiments, the second cap includes an interior surface having aplurality of tortuous path rings.

In one or more embodiments, a collar is attached to the closed distalend of the second cap, the collar comprising a second permeable materialthat covers the closed distal end of the second cap.

In one or more embodiments, a tamper-evident band covers a portion of atleast one of the first and second cap.

In one variant, the first or second cap can comprise a plurality ofopenings in flow communication with the fluid path and permitsterilization of a portion of the fluid path using radiation or a gas.In one or more embodiments, the plurality of openings are selected fromholes or slots.

In one or more embodiments, the first cap comprises a plurality ofopenings on the first segment that are radiation and gas permeable andare in flow communication with the fluid path by radiation or a gas. Inone or more embodiments, the plurality of openings are selected fromholes or slots.

In one or more embodiments, the second cap comprises a plurality ofopenings on the second segment of the second cap that are radiation andgas permeable ad in flow communication with the fluid path andpermitting sterilization of a portion of the fluid path by radiation ora gas. In one or more embodiments, the plurality of openings areselected from holes or slots.

In one or more embodiments, the syringe assembly is not surrounded byany external packaging. The external packaging can be a blister pack.

In one or more embodiments, the syringe assembly is sterile.

In one or more embodiments, the first cap is attached to the barrelusing at least one heat stake. In one or more embodiments, the secondcap is attached to the barrel using at least one heat stake.

In one or more embodiments, the surface of the barrel has a mattefinish. In one or more embodiments, the first cap has a matte finish. Inone or more embodiments, the second cap has a matte finish. In one ormore embodiments, the barrel further comprises a transparent labelaffixed to the outer surface of the side wall of the barrel.

In one or more embodiments, the syringe assembly is stored inside aTyvek® bag with a plurality of other packageless syringe assemblies.

In one or more embodiments, each of the first and second caps is coveredwith a tamper-evident band.

A second aspect of the present invention is directed to a packagelesssyringe assembly including a fluid path that can be sterilized by gas orradiation comprising a barrel a barrel including a side wall having anoutside surface and an inside surface defining a chamber for retainingfluid, an open proximal end, and a distal end including a distal wall,the chamber, distal end and proximal end defining a fluid path; aplunger rod including a stopper disposed within the barrel; a first caphaving a proximal end having a plurality of openings in flowcommunication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas and an open distal endaffixed to the proximal end of the barrel, wherein the first capproximal end is covered by a first permeable material; a second capaffixed to the distal end of the barrel, the second cap having aproximal end and a closed distal end with a plurality of openings inflow communication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas; a collar attached tothe closed distal end of the second cap, the collar comprising a secondpermeable material that covers the openings on the closed distal end ofthe second cap; and a tamper-evident band covering a portion of at leastone of the first and second cap.

A further aspect of the present invention pertains to a method ofsterilizing the fluid path of a syringe assembly. The method accordingto one embodiment comprises using radiation or a gas to sterilize thefluid path of a syringe assembly, wherein the syringe assembly includesa plunger rod, a syringe barrel, and a first and second cap that permitsterilization of a portion of the fluid path by radiation or a gas. Themethod allows the fluid path to remain sterile without the need forexternal packaging material surrounding the syringe assembly.

In one or more embodiments, the barrel includes a side wall having anoutside surface and an inside surface defining a chamber for retainingfluid, an open proximal end, and a distal end including a distal wall,the chamber, distal end and proximal end defining a fluid path.

In one or more embodiments, the plunger rod includes a stopped disposedwithin the barrel.

In one or more embodiments, the first cap has a proximal end having afirst segment that is radiation and gas permeable and is in flowcommunication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas, and an open distal endaffixed to the proximal end of the barrel, wherein the first capproximal end is optionally covered by a first permeable material.

In one or more embodiments, the second cap is affixed to the distal endof the barrel, and has a proximal end and a closed distal end having asecond segment that is radiation and gas permeable and is in flowcommunication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas.

In one or more embodiments, a collar is attached to the closed distalend of the second cap, the collar comprising a second permeable materialthat covers the closed distal end of the second cap; and atamper-evident band covering a portion of at least one of the first andsecond cap.

In one or more embodiments, the radiation is selected from E-beam andcobalt.

In one or more embodiments, the gas is ethylene oxide.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an assembled syringe assembly accordingto an embodiment of the present invention;

FIG. 2 is an exploded perspective view of a syringe assembly accordingto an embodiment of the present invention;

FIG. 3A is an end view of the first cap which attaches to the syringeassembly of FIG. 1;

FIG. 3B is an end view of the first cap which attaches to the syringeassembly of FIG. 1;

FIG. 3C is an end view of the first cap which attaches to the syringeassembly of FIG. 1;

FIG. 4 is an end view of the first cap which attaches to the syringeassembly of FIG. 1;

FIG. 5A is an end view of the second cap attaches to the syringeassembly of FIG. 1;

FIG. 5B is an end view of the second cap which attaches to the syringeassembly of FIG. 1;

FIG. 6 is a perspective view of the first cap which attaches to thesyringe assembly of FIG. 1;

FIG. 7 is a perspective view of the second cap which attaches to thesyringe assembly of FIG. 1; and

FIG. 8 is a perspective view the barrel label according to an embodimentof the present invention.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

With respect to terms used in this disclosure, the following definitionsare provided.

Reference to “syringe assembly” includes syringes that are indicated foruse with needles, nozzle, tubing, or for use in flush systems.

As used herein, the use of “a,” “an,” and “the” includes the singularand plural.

As used herein, the term “packageless” refers to syringe assemblies thatare not surrounded by external packing material, including, but notlimited to, flexible and rigid blister packs.

As used herein, the term “tortuous path” refers to a long knownprinciple established by Louis Pasteur. In experiments, Pasteurfashioned glass flasks with various neck shapes. Each flask contained anenclosed sterile media. The necks on some flasks allowed microorganismsto fall on the contained media, which then became contaminated asevidenced by bacterial growth. The media in flasks with S-curved necks,or in those flasks which presented a “tortuous path” for microorganisms,remained sterile. The microorganisms were stopped at the openings to thecurved necks, as well as at the curves in the necks.

As used herein, the term “tortuous path ring” refers to a ring, circle,loop, band, sphere, etc. that creates a barrier between the contaminatedexterior and the sterile interior region of the syringe assembly bycreating a extended pathway with a plurality of interruptions thatprevents the migration of microorganisms from the outside of the syringeassembly into the sterile fluid path.

As used herein, the term “microorganism” refers to a microbe or organismthat is unicellular or lives in a colony of cellular organisms.Microorganisms are very diverse; they include, but are not limited tobacteria, fungi, archaea, and protozoans.

As used herein, the terms “heat staking” and “heat stake” refer to aprocess of connecting two components by creating an interference fitbetween the two pieces. A plastic stud protruding from one componentfits into the hole in a second component. The plastic stud is thendeformed through the softening of the plastic via heat to form a headwhich mechanically locks the two components together.

As used herein, the term “permeable material” refers to any medicalgrade material such as a paper or fabric which is breathable andpermeable to gas, but is not permeable to microorganisms. Medical gradepackaging materials such as papers or woven materials have a typicalporosity between 8 and 400 seconds/100 mL as defined by ASTM D-726 orISO 5636. These materials must provide a microbial barrier as defined byASTM F-1608 and/or F-2638. These materials can be provided with anantimicrobial agent or disinfectant integral with or converted coatingof the material. Medical grade materials can include, but are notlimited to, medical grade papers and Tyvek®. Typical suppliers caninclude, but are not limited to, Arjo-Wiggins, Billerud, Domtar, Neenah,Hansol, and Dupont.

Tyvek® is a synthetic material consisting of flashspun high-densitypolyethylene fibers (i.e. a spunbound olefin fiber). The material islightweight and strong, and is resistant to tearing but can be cut withscissors or a knife. Water vapor and other gases can pass through Tyvek®as the material is highly breathable, but, at the same time, thematerial is impermeable to liquid water and microorganisms.

As used herein, the terms “antimicrobial agent” or “antimicrobial”refers to substances that kill or inhibit the growth of microorganismssuch as bacteria, fungi, archaea, or protozoans. Antimicrobial agentseither kill microbes, or prevent the growth of microbes.

As used herein, the term “disinfectant” refers to antimicrobialsubstances that are used on non-living objects or outside the body,e.g., on the skin.

Disinfectants or antimicrobial agents can include, but are not limitedto, ethanol, 2-propanol, butanol, methylparaben, ethylparaben,propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylatedhydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine,dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan,hydrogen peroxide, colloidal silver, and mixtures thereof.

As used herein, the term “sterilization” refers to a means ofeliminating or killing microorganisms present on a surface, contained ina fluid, or in a compound such as biological culture media in order toachieve asepsis or a sterile microbial environment. Sterilization can beachieved by applying heat, chemicals, irradiation/radiation, highpressure, filtration, or combinations thereof. Chemical sterilizationincludes sterilization with gases such as ethylene oxide, hydrogenperoxide gas, and ozone, liquids such as chlorine bleach, iodine,glutaraldehyde and formaldehyde, ortho-phthaladehyde (OPA), hydrogenperoxide, peracetic acid, sodium hydroxide, silver, and cobalt.Radiation sterilization involves the use of radiation such as electronbeams (E-beam), x-rays, gamma rays, or subatomic particles.

As used herein, the terms “ethylene oxide” or “EO” or “EtO” refer to agas that is commonly used to sterilize objects sensitive to temperaturesgreater than 65° C. and/or radiation, such as plastics, optics andelectrics. Ethylene oxide sterilization is generally carried out between30° C. and 65° C. with relative humidity above 30% and a gasconcentration between 200 and 1000 mg/L. Typical EtO exposure lasts forat least two or more hours with additional time allowed for pre and postconditioning. Ethylene oxide is highly effective at sterilization andpenetrates well, moving through permeable papers, cloth, and someplastic films. Ethylene oxide can kill all known microorganisms,including viruses, bacteria, and fungi. Ethylene oxide is highlyflammable, toxic, and carcinogenic.

Ethylene oxide sterilization typically consists of a preconditioningphase, the actual sterilization run, and a period of post-sterilizationaeration to remove toxic residues, such as ethylene oxide residues andby-products such as ethylene glycol and ethylene chlorohydrine. The twomost significant ethylene oxide sterilization methods as: (1) the gaschamber method, and (2) the micro-dose method. The gas chamber methodinvolves flooding a large chamber with a combination of ethylene oxideand other gases used as dilutants. This method has drawbacks inherent tothe use of large amounts of ethylene oxide being releases into a largespace, including air contamination produced by CFCs and/or large amountsof ethylene oxide residuals, flammability and storage issues calling forspecial handling and storage, operator exposure risk and training costs.

Gamma rays are very penetrating and are commonly used for sterilizationof disposable medical equipment, such as syringes, needles, cannulas,and IVs. Gamma radiation requires bulky shielding for the safety of theoperators; it also requires storage of a radioisotope (usuallyCobalt-60), which continuously emits gamma rays.

As used herein, the term “cobalt” or “cobalt-60” refers to cobalt-60,which is a synthetic radioactive isotope of cobalt; it is a hard,gray-blue metal and might appear as small metal disks or in a tube,enclosed at both ends, that holds the small disks. Cobalt-60 can occuras a powder if the solid sources have been ground or damaged. Cobalt-60is used medically for radiation therapy as implants and as an externalsource of radiation exposure. Cobalt-60 is also used industrially inleveling gauges and to x-ray welding seams and other structural elementsto detect flaws. Additionally, cobalt-60 is used for food irradiationand other sterilization processes. Cobalt-60 decays by gamma radiation.External exposure to large sources of Cobalt-60 can cause skin burns,acute radiation sickness, or death

As used herein, the term “E-beam” refers to electron beam (E-beam)processing, which is commonly used for medical sterilization. Electronbeams use an on-off technology and provide a much higher dosing ratethan gamma or x-rays. Due to the higher dose rate, less exposure time isneeded, and, thereby, any potential degradation to polymer materials isreduced. A limitation is that electron beams are less penetrating thaneither gamma rays or x-rays.

Provided are syringe assemblies that include a plunger rod and a syringebarrel and a first and second cap, that incorporate elements forsterilizing the fluid path without the need for external packagingsurrounding the syringe assembly. The assembled syringe is shown in FIG.1, with the components and alternative embodiments of the presentinvention shown in FIGS. 2-8. Referring to FIGS. 1 and 2, a packagelesssyringe assembly 20 according to the present invention includes a fluidpath that can be sterilized by gas or radiation and generally comprisesa barrel 21, including a side wall having an outside surface and aninside surface for defining a chamber for retaining fluid. The barrel 21further includes an open proximal end 22 and a distal end 23, thechamber distal end 23 and proximal end 22 defining a fluid path.

A plunger rod 24 including a stopper 25 that is slidably positioned influid-tight engagement with the inside surface of the barrel for drawingfluid into and driving fluid out of the chamber by movement of thestopper 25 relative to the barrel 21, the plunger rod 24 extendingoutwardly from the open proximal end 22 of the barrel.

Referring to FIG. 3A, in one or more embodiments, a first cap 26including a proximal end 27 having a first segment 28 that is radiationand gas permeable and is in flow communication with the fluid pathpermitting sterilization of a portion of the fluid path by radiation ora gas, an open distal end 29 affixed to the proximal end 22 of thebarrel 21.

Referring to FIG. 3B, in one or more embodiments, the first cap proximalend 27 is optionally covered by a first permeable material 30. In one ormore embodiments, the first permeable material 30 comprises a medicalgrade paper with a porosity of 30-400 seconds/100 mL or Tyvek® with aporosity of 8-40 seconds/100 mL. Both materials are porous forbreathability, but also provide a microbial barrier. A tamper evidentband 37 may cover a portion of the open distal end 29 of the first cap26. The proximal end 27 of the first cap 26 may include acircumferential lip 40 defining a recess containing the first permeablematerial 30. The packageless syringe assembly 20 can further comprise aplurality of openings 38B on the first segment 28 of the first cap 26that are radiation and gas permeable and are in flow communication withthe fluid path and permitting sterilization of a portion of the fluidpath by radiation or a gas. In a specific embodiment, the plurality ofopenings 38B comprise slots.

Referring to FIG. 3C, in one or more embodiments, the first cap proximalend 27 is optionally covered by a first permeable material 30. In one ormore embodiments, the first permeable material 30 comprises a medicalgrade paper with a porosity of 30-400 seconds/100 mL or Tyvek® with aporosity of 8-40 seconds/100 mL. Both materials are porous forbreathability, but also provide a microbial barrier. A tamper evidentband 37 may cover a portion of the first cap. The proximal end 27 of thefirst cap 26 may include a circumferential lip 40 defining a recesscontaining the first permeable material 30. The packagless syringeassembly 20 can further comprise a plurality of openings 38C on thefirst segment 28 of the first cap 26 that are radiation and gaspermeable and are in flow communication with the fluid path andpermitting sterilization of a portion of the fluid path by radiation ora gas. In a specific embodiment, the plurality of openings 38C compriseholes.

Referring to FIG. 4 the first cap 26 may include an interior surfacehaving a plurality of tortuous path rings 41. The tortuous path rings 41create a barrier between the contaminated exterior and the sterileinterior region of the syringe assembly by creating a long pathway witha plurality of interruptions that prevents the migration ofmicroorganisms from the outside of the syringe assembly into the sterilefluid path. The first cap 26 may also include a tamper evident band 37covering a portion of the open distal end 29 of the first cap.

Referring to FIGS. 5A and 5B, a second cap 31 affixed to the distal end23 of the barrel 21, the second cap 31 having a proximal end 32 and adistal end 33 having a second segment 34 that is radiation and gaspermeable and is in flow communication with the fluid path andpermitting sterilization of a portion of the fluid path or a gas. Thesecond cap 31 may include an interior surface having a plurality oftortuous path rings 41. The tortuous path rings 41 create a barrierbetween the contaminated exterior and the sterile interior region of thesyringe assembly by creating a long pathway with a plurality ofinterruptions that prevents the migration of microorganisms from theoutside of the syringe assembly into the sterile fluid path.

Optionally, a collar 35 is attached to the distal end 33 of the secondcap 31, the collar 35 comprising a second permeable material 36 thatcovers the closed distal end 33 of the second cap 31; and a tamperevident band 37 covering a portion of at least one of the first cap 26and the second cap 31.

The packageless syringe assembly 20 can further comprise a plurality ofopenings 39 on the second segment 34 of the second cap 31 that areradiation and gas permeable and are in flow communication with the fluidpath and permitting sterilization of a portion of the fluid path byradiation or a gas. In a specific embodiment, the plurality of openingsare selected from holes and slots.

Referring to FIGS. 6 and 7, the first cap 26 may be attached to thebarrel 21 using at least one heat stake 43. The second cap 31 may beattached to the barrel 21 using at least one heat stake 43. The secondcap 31 may be attached to the barrel 21 using at least one heat state43.

In a specific embodiment, each of the first cap 26 and the second caps31 is covered with a tamper-evident band 37. In one or more embodiments,the outside surface of the barrel 21 has a matte finish. The texture ofthe substrate on which the tamper evident band 37 will sit willinfluence how well the tamper evident band 37 adheres to the body of thesyringe barrel 21 and to the first cap 26 and the second cap 31. A mattefinish will provide a better surface for adherence of the tamper evidentband 37 than a smooth/shiny surface.

Referring to FIGS. 1 and 8, the barrel 21 may further comprise atransparent label 44 affixed to the outer surface of the side wall ofthe barrel 21.

The syringe assembly 20 can be sterile. The fluid path of the syringeassembly 20 can be sterilized using radiation or a gas. Radiation caninclude, but is not limited to, E-beam, or gamma radiation. Gammaradiation involves the use of the radioactive isotope Cobalt-60. Gassterilization can include, but is not limited to, ethylene oxidesterilization.

In one or more embodiments, the packageless syringe assembly 20 is notsurrounded by any external packaging material. External packagingmaterial includes, but is not limited to flexible and rigid blisterpacks.

The syringe assembly 20 may be stored in a Tyvek® bag with a pluralityof other packageless syringe assemblies.

One or more embodiments of the present invention provides for a methodof sterilizing the fluid path of a syringe assembly. The methodcomprising subjecting a syringe assembly to radiation or a gas. Thesyringe assembly is as described in FIGS. 1-8. The syringe assembly cancomprise a barrel including a side wall having an outside surface and aninside surface defining a chamber for retaining fluid, an open proximalend, and a distal end including a distal wall, the chamber, distal endand proximal end defining a fluid path; a plunger rod including astopper disposed within the barrel; a first cap having a proximal endhaving a first segment that is radiation and gas permeable and is inflow communication with the fluid path and permitting sterilization of aportion of the fluid path by radiation or a gas, and an open distal endaffixed to the proximal end of the barrel, wherein the first capproximal end is optionally covered by a first permeable material; asecond cap affixed to the distal end of the barrel, the second caphaving a proximal end and a closed distal end having a second segmentthat is radiation and gas permeable and is in flow communication withthe fluid path and permitting sterilization of a portion of the fluidpath by radiation or a gas; optionally, a collar attached to the closeddistal end of the second cap, the collar comprising a second permeablematerial that covers the closed distal end of the second cap; and atamper-evident band covering a portion of at least one of the first andsecond cap.

In one or more embodiments, the sterilization of the syringe assembly iscarried out using radiation. The radiation can be selected from E-beamand cobalt.

In one or more embodiments, the sterilization of the syringe assembly iscarried out using gas sterilization. The gas can be ethylene oxide.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as disclosed.

What is claimed is:
 1. A packageless syringe assembly including a fluid path that can be sterilized by gas or radiation comprising: a barrel including a side wall having an outside surface and an inside surface defining a chamber for retaining fluid, an open proximal end, and a distal end including a distal wall, the chamber, distal end and proximal end defining a fluid path; a plunger rod including a stopper disposed within the barrel; a first cap having a proximal end having a plurality of openings in flow communication with the fluid path and permitting sterilization of a portion of the fluid path by radiation or a gas, an interior surface having a plurality of tortuous path rings, and an open distal end affixed to the proximal end of the barrel, wherein the first cap proximal end is covered by a first permeable material; a second cap affixed to the distal end of the barrel, the second cap having a proximal end, an interior surface having a plurality of tortuous path rings, and a closed distal end with a plurality of openings in flow communication with the fluid path and permitting sterilization of a portion of the fluid path by radiation or a gas; a collar attached to the closed distal end of the second cap, the collar comprising a second permeable material that covers the openings on the closed distal end of the second cap; and a tamper-evident band covering a portion of at least one of the first and second cap.
 2. The packageless syringe assembly of claim 1, wherein the syringe assembly is not surrounded by an external packaging material.
 3. The packageless syringe assembly of claim 2, wherein the external packaging material is a blister pack.
 4. The packageless syringe assembly of claim 1, wherein the plurality of openings are holes.
 5. The packageless syringe assembly of claim 1, wherein the plurality of openings are slots.
 6. The packageless syringe assembly of claim 1, wherein the syringe assembly is sterile.
 7. The packageless syringe assembly of claim 1, wherein the first permeable material has a porosity of 8-400 seconds/100 mL.
 8. The packageless syringe assembly of claim 1, wherein the proximal end of the first cap includes a circumferential lip defining a recess containing the first permeable material.
 9. The packageless syringe assembly of claim 1, wherein the first cap is attached to the barrel using at least one heat stake.
 10. The packageless syringe assembly of claim 1, wherein the second cap is attached to the barrel using at least one heat stake.
 11. The packageless syringe assembly of claim 1, wherein the outside surface of the barrel has a matte finish.
 12. The packageless syringe assembly of claim 1, wherein the barrel further comprises a transparent label affixed to the outer surface of the side wall of the barrel.
 13. The packageless syringe assembly of claim 1, wherein the radiation is selected from E-beam and cobalt.
 14. The packageless syringe assembly of claim 1, wherein the gas is ethylene oxide.
 15. A method of sterilizing the fluid path of a syringe assembly, the method comprising subjecting a syringe assembly to radiation or a gas, wherein the syringe assembly comprises a barrel including a side wall having an outside surface and an inside surface defining a chamber for retaining fluid, an open proximal end, and a distal end including a distal wall, the chamber, distal end and proximal end defining a fluid path; a plunger rod including a stopper disposed within the barrel; a first cap having a proximal end having a first segment that is radiation and gas permeable and is in flow communication with the fluid path and permitting sterilization of a portion of the fluid path by radiation or a gas, and an open distal end affixed to the proximal end of the barrel, wherein the first cap proximal end is optionally covered by a first permeable material; a second cap affixed to the distal end of the barrel, the second cap having a proximal end and a closed distal end having a second segment that is radiation and gas permeable and is in flow communication with the fluid path and permitting sterilization of a portion of the fluid path by radiation or a gas; optionally, a collar attached to the closed distal end of the second cap, the collar comprising a second permeable material that covers the closed distal end of the second cap; and a tamper-evident band covering a portion of at least one of the first and second cap.
 16. The method of claim 15, wherein the radiation is selected from E-beam and cobalt.
 17. The method of claim 15, wherein the gas is ethylene oxide. 